PathwaysGlobal Market Access & Regulatory Strategy
Navigate country-specific requirements, certification pathways, and market-entry decisions.
Problems We Solve
Solve What Stands Between Your Product and the Market.
Relentless commitment to your success
When compliance gets difficult, ORBIS stays alongside your team, takes ownership of the problem, and helps keep the path to approval moving.
Lived engineering and regulatory partnership in action
We work alongside your team. We understand the complexity. We take ownership of the problem. We help move the product forward.
Real Challenges. Practical Solutions. Measurable Impact.
Some of the problemswe solve every day.
Regulatory barriers rarely arrive one at a time. ORBIS works alongside your team to resolve the technical, regulatory, documentation, and execution issues that can hold products back from market.
Pathways
ResolutionProduct Classification & Specialized Compliance
Resolve classification, testing, spectrum, documentation, and compliance issues that can block approval.
ExecutionTesting, Certification & Logistics
Keep testing, samples, laboratories, certification activity, and logistics moving toward the launch date.
GovernanceDocumentation, Translation & Legal Support
Make sure the right documentation and regulatory support are ready when the approval path requires them.
One accountable partner. Every approval path visible.
Proof in the real world
When the challenge is difficult,the outcome matters.
Featured: Consumer Electronics | Mexico
48 hours to protect a critical holiday launch.
A global gaming company faced homologation delays in Mexico that threatened its holiday launch. ORBIS audited the application, worked directly with IFT, and helped resolve the approval issue.
Computer Networking | Brazil
Turning a costly testing barrier into a faster approval path
A global networking manufacturer faced major cost and delay shipping a 350-pound data switch to Brazil for EMC testing. ORBIS built a technical and legal case for using existing U.S. test reports, and ANATEL accepted the approach.
- 4 → 2
- Approval process (in months)
- $500k
- Estimated testing / certification savings
- $4M
- Estimated additional revenue achieved
Consumer Electronics | Import
Removing multiple and redundant bottlenecks.
A consumer electronics company was facing import blocks, repeated certificates, and a file that did not match the product. ORBIS reduced the duplicate work and put one path in front of the authority.
- 45 → 3
- Filings brought into one path
- 30 → 12
- Weeks to a usable approval
- $4M
- Estimated exposure avoided
Industrial | Documentation
A product file rebuilt before the certificate stalled.
A machinery manufacturer was missing certificates and carrying incorrect documentation. ORBIS sequenced the evidence and kept the certification work moving.
- 184
- Products and parts assessed
- 175
- Required certifications
Medical Devices | Global
Mapping a compliance path across 128+ countries.
A U.S. medical device team needed one view of requirements, regions, and local support. ORBIS mapped the path so the same product record could travel with the launch.
- 3 regions
- Covered in the first pass
- 128+ countries
- Requirements mapped
Different challenges. One Mission:Get every product approved.
